FDA.reportPublic FDA data

Stool Softener Laxative

Manufacturer
Strategic Sourcing Services LLC
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:26:35

Label at a glance#

ProductStool Softener Laxative
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Dosage and administration

take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-3 softgels daily  children 2 to under 12 years of age  take 1 softgel daily  children under 2 years  ask a doctor 

Storage and handling

each softgel contains :sodium 5 mg store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts over 14 days

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and overtake 1-3 softgels daily 
children 2 to under 12 years of age take 1 softgel daily 
children under 2 years ask a doctor 

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains:sodium 5 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, anhydrous citric, D&C red #33, ethyl alcohol, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mineral oil, n-butyl alcohol, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1--833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO COLACE® REGULAR STRENGTH STOOL SOFTENER ACTIVE INGREDIENT*

REGULAR STRENGTH

Stool Softener

Docusate Sodium 100 mg

STOOL SOFTENER LAXATIVE

  • Gentle & Effective
  • Relieves Constipation
  • Stimulant-Free

SOFTGELS

*This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc.,distributor of Colace® Regular Strength Stool Softener.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by: McKesson Corp.,

via SSSL Memphis, TN 38141

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FOSTER & THRIVE Regular Strength Stool Softener
FOSTER & THRIVE Regular Strength Stool Softener

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN3
1115005docusate sodium 100 MG Oral CapsuleSCD3
1115005DOSS Sodium 100 MG Oral CapsuleSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130010939956323GTIN-13: 0010939956323
EAN-13: 0010939956323
GTIN-12: 010939956323
UPC-A: 010939956323
GTIN storage (14 digits): 00010939956323		docusate-sodium-2-tone-100-mg-softgel-pur-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1095-1Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1003
70677-1095-2Stool Softener Laxative250 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1095-1EA - Each70677-1095bff1561a-4e78-4a1b-8654-99e3187c838412023-09-05
70677-1095-2EA - Each70677-1095eeed03d0-f58c-40a0-92d8-3a187ec37fc412023-09-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-109570677-1095-1, 70677-1095-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
AMMONIA5138Q19F1XIACT
ISOPROPYL ALCOHOLND2M416302IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MINERAL OILT5L8T28FGPIACT
BUTYL ALCOHOL8PJ61P6TS3IACT
ALCOHOL3K9958V90MIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMStrategic Sourcing Services LLCba51cca1-b70b-476e-80e6-20cd52292e652025-12-17WarningsExact identifier
ndc (package): 70677-1095-2
ndc (package): 70677-1095-1
ndc (product): 70677-1095
ndc11 (package): 70677109501
ndc11 (package): 70677109502
spl id: 62b6d6c3-d888-4358-90d2-7ac0a046b8bf
spl set id: ba51cca1-b70b-476e-80e6-20cd52292e65

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.